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Botanical and Plant-Derived Drugs: Global Markets

  • August 2015
  • -
  • BCC Research
  • -
  • 172 pages

This BCC Research report analyzes the key growth areas in plant derived drugs, develops quantitative market projections and discusses compliance with the requirements for the botanical category of drugs, created in 2004, with its own U.S. Food and Drug Administration (FDA) regulations, guidelines and review process through 2020.

REPORT HIGHLIGHTS

The global market for botanical and plant-derived drugs was valued at $23.2 billion in 2013 and $24.4 billion in 2014. This total market is expected to reach $25.6 billion in 2015 and nearly $35.4 billion in 2020, with a compound annual growth rate (CAGR) of 6.6% from 2015 to 2020.

This report provides:

- An overview of the botanical drug industry, with the overall plant-derived drug industry as a backdrop and the global market for these drugs going forward.
- Analyses of global market trends, with data from 2013 and 2014, estimates for 2015, and projections of CAGRs through 2020.
- A focus on legal, prescription-required therapeutic medicines sold in the open market; the study does not specifically cover herbals generally sold as dietary supplements (i.e., to promote overall “wellness” rather than to address a specific medical condition or symptoms).
- Examination of the industry structure, competition, and market drivers.
- Discussion of market size and segmentation, including breakdowns of sales by therapeutic area and geographic area.
- Observations and conclusions regarding the future of the botanical and plant-derived drug industry.

SCOPE OF REPORT

This report is an analytical business tool whose primary purpose is to describe the botanical drug industry with the overall plant-derived drug industry as a backdrop and the global market for these drugs going forward.

For the purposes of this report, botanicals are those drugs that are FDA-approved under the botanical drug pathway, while plant-derived drugs are both botanicals as well as other approved drugs that contain a mixture of natural plant-derived and synthetic or semisynthetic substances.

The study’s main focus is on legal, prescription-required therapeutic medicines sold in the open market. The study does not specifically cover herbals generally sold as dietary supplements (i.e., to promote overall “wellness” rather than to address a specific medical condition or symptoms). While there is a substantial market for these products, the medical value of many of these substances has not been demonstrated conclusively.

The study also does not cover the following:

- Underground or illicit drugs.
- Home remedies.
- Tribal medicines.
- Drugs derived from Archaea, bacteria and fungi (molds and yeasts).
- Nonmedicinal plant substances such as laxative cellulose and pectin fiber.
- Intravenously delivered nutrients of plant origin, such as dextrose.
- Plant-derived substances serving as pharmaceutical excipients, such as starch, methylcellulose, guar gum, vegetable oils, fatty acids, cocoa butter and candelilla wax.
- Plant substances serving in cosmetics, toiletries and personal care products.
- Microbial fermentation products, even those made with culture media incorporating corn steep liquor, starch or other plant-derived nutrients.
- Marine life.
The format of the study is organized around the following topics:
- Major types and applications of botanical drugs with plant-derived drugs as their backdrop.
- Industry structure.
- Market size and segmentation, including the breakdown of sales by therapeutic area and geographic area.
- Market drivers.
- Market projections through 2020.
- Competition.
- Observations and conclusions regarding the future of the botanical and plant-derived drug industry.

Table Of Contents

Botanical and Plant-Derived Drugs: Global Markets
CHAPTER 1 INTRODUCTION 2
STUDY BACKGROUND 2
STUDY GOAL AND OBJECTIVES 2
INTENDED AUDIENCE 3
SCOPE OF REPORT 3
METHODOLOGY AND INFORMATION SOURCES 4
COMMERCIAL DRUGS 4
DEVELOPMENTAL DRUGS 4
TABLE A FDA APPROVAL PROCESS FOR NEW DRUGS 5
ANALYST'S CREDENTIALS 5
RELATED BCC RESEARCH REPORTS 6
BCC RESEARCH WEBSITE 6
DISCLAIMER 6
CHAPTER 2 SUMMARY 8
SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED
DRUGS, THROUGH 2020 ($ MILLIONS) 10
SUMMARY FIGURE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED
DRUGS, 2013-2020 ($ MILLIONS) 10
CHAPTER 3 OVERVIEW 16
BRIEF HISTORY OF PLANT-DERIVED MEDICINES 17
TABLE 1 KEY DATES IN BOTANICAL MEDICINE 18
TABLE 2 WELL KNOWN PLANT-DERIVED DRUGS 18
OPPORTUNITY LIES BEYOND WHAT IS KNOWN 19
FIGURE 1 TYPE OF NATURAL PRODUCT DRUGS SUBMITTED AS IND APPLICATIONS
TO THE FDA, 2008 (% SHARES) 19
GETTING STARTED 22
KEY DRIVERS 23
KEY CHALLENGES 24
U.S. GOVERNMENT INVESTMENT 25
INDUSTRY INVESTMENT 27
TABLE 3 SWOT ANALYSIS OF BOTANICAL DRUG DEVELOPMENT 32
TABLE 4 KEY INVESTMENTS IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 34
NUTRITION SCIENCE PARTNERS LTD. (NESTLE HEALTH): A CASE STUDY 38
BOTANICAL DRUGS DEFINED 40
UNDERSTANDING THE REGULATORY PROCESS 42
TABLE 5 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 43
INVESTIGATIONAL NEW DRUG APPLICATIONS 43
CLINICAL TRIALS 44
NEW DRUG APPLICATION 44
THE FIRST AND SECOND APPROVED BOTANICAL 45
VEREGEN (CHINESE GREEN TEA CATECHINS) 45
Advice from FDA Based on Veregen Approval 46
FULYZAQ (CROFELEMER) 47
BOTANICAL CANDIDATES IN THE PIPELINE 48
SAMITAL AND PANAX GINSENG 48
TCM-700C 49
FEMARELLE AND BRIZO 50
SHINBARO CAPSULE 51
DANSHEN DRIPPING PILL (CARDIOTONIC PILL) 51
EISO (EAST INDIAN SANDALWOOD OIL) 53
MICROBIO AND WH-1, MB-6, AND OB318 55
TABLE 6 BOTANICAL COMPOSITION OF MENERBA (MF 101)* 56
A GROWING PIPELINE 57
FIGURE 2 TOP THERAPEUTIC AREAS OF FDA DRUG APPROVALS*, 2014 (NO. OF
DRUG APPROVALS) 57
FIGURE 3 SNAPSHOT OF U.S. FDA BOTANICAL PIPELINE IN 2012 58
OVERALL PHARMA LANDSCAPE 59
TABLE 7 TOP PHARMA COMPANIES BY SALES, 2014 ($ BILLIONS) 61
TABLE 8 MAJOR UPCOMING U.S. PATENT EXPIRIES, 2014-2019 62
FIGURE 4 PHARMA DRUG SALES BY REGION, 2014 AND 2019 (% OF MARKET
SHARE) 62
MAJOR CLASSES OF PLANT DRUGS 63
Terpenes and Steroids 63
Terpenes 63
Steroids 64
Alkaloids and Glycosides 64
Alkaloids 64
Ergot Alkaloids 65
Morphine Alkaloids 65
Vinca Alkaloids 65
Glycosides 66
Cardiac Glycosides 66
Anthraglycosides 66
Phenols 66
E. Cava Algae 66
Flavonoids 66
Resveratrol 67
Coumarin 67
Catechins 67
Proanthocyanidins 67
INTELLECTUAL PROPERTY 68
PRODUCTION 69
A NEW TYPE OF PRODUCTION: PLANT-MADE DRUGS 71
MOVING PRODUCTION FORWARD 72
ARTEMISININ: A CASE STUDY 75
SUPPLY AND LEGAL ISSUES 76
TABLE 9 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 77
DRUG DEVELOPMENT AND MANUFACTURE 78
TABLE 10 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES 79
CHAPTER 4 MARKET SEGMENTATION 82
GEOGRAPHIC SEGMENTATION 82
SALES OF PLANT-DERIVED DRUGS BY REGION 82
THERAPEUTIC AREA SEGMENTATION 82
NUMBER OF PLANT-DERIVED DRUGS BY THERAPEUTIC AREA 82
TABLE 11 NUMBER OF FDA APPROVED BOTANICAL DRUGS, THROUGH 2020
(NUMBER) 82
FIGURE 5 COMPOSITION OF FDA APPROVED BOTANICAL INDICATIONS FORECAST
BY THERAPEUTIC AREA, 2015 AND 2020 (%) 83
VALUE OF PLANT-DERIVED DRUGS BY THERAPEUTIC AREA 84
TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY
THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS) 84
FIGURE 6 RELATIVE VALUE SHARE OF FDA APPROVED BOTANICAL DRUGS
FORECAST BY THERAPEUTIC AREA, 2015 AND 2020 (%) 84
CHAPTER 5 THERAPEUTIC AREAS FOR BOTANICAL AND PLANT-DERIVED DRUGS 87
HORMONE THERAPY AND METABOLISM APPLICATIONS 87
TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS IN LATE
STAGE DEVELOPMENT 88
INFECTIOUS DISEASE APPLICATIONS 88
TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE
DEVELOPMENT 89
PAIN AND CENTRAL NERVOUS SYSTEM DISEASE APPLICATIONS 91
TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE DRUGS 91
TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE DEVELOPMENT 92
CARDIOVASCULAR AND METABOLIC DISEASE APPLICATIONS 94
TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE
STAGE DEVELOPMENT 94
RESPIRATORY, INFLAMMATION (BOTH NONRELATED AND RELATED TO
ORTHOPEDIC) AND AUTOIMMUNE APPLICATIONS 95
TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION (BOTH NON-RELATED
AND RELATED TO ORTHOPEDIC) AND AUTOIMMUNE DRUGS IN LATE STAGE
DEVELOPMENT
95
DERMATOLOGY APPLICATIONS 96
TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE STAGE
DEVELOPMENT 97
GASTROINTESTINAL APPLICATIONS 97
TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE
DEVELOPMENT 98
ONCOLOGY APPLICATIONS 99
TABLE 21 ESTIMATED U.S. CANCER CASES BY GENDER, 2015 99
TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE DEVELOPMENT 102
BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT 108
TABLE 23 BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT WITH POSSIBLE
FDA-APPROVED COMMERCIALIZATION, THROUGH 2020 109
CHAPTER 6 COMPANY PROFILES 113
ABBOTT LABORATORIES 113
ACORDA THERAPEUTICS, INC. 113
AMAREX CLINICAL RESEARCH 114
ANALYTICON DISCOVERY GMBH 114
ARTECEF BV 115
AVESTHAGEN LTD. 115
BAYER HEALTHCARE PHARMACEUTICALS 116
BEIJING PEKING UNIVERSITY WBL BIOTECH CO. LTD. 117
BIONORICA SE 118
BIONUMERIK PHARMACEUTICALS INC. 118
BOEHRINGER INGELHEIM 119
PHARMATON SA 119
BOTANICAL DRUG CORP. 120
BRISTOL MYERS SQUIBB 121
CARDAX PHARMACEUTICALS 124
CHI-MED 125
CHONG KUN DANG PHARMACEUTICAL CORP. 125
CURAPHARM INC. 126
DONG-A-ST 126
DONGWHA PHARM CO. LTD. 127
EISAI INC. 127
EISAI, INC. U.S. 127
EKOMED LLC 128
ELI LILLY 129
FYTOKEM PRODUCTS INC. 129
GALAPAGOS NV 130
GENSPERA INC. 131
GLAXOSMITHKLINE 131
GLENMARK PHARMACEUTICALS LIMITED 133
GREEN CROSS CORP. 133
GREEN LABORATORIES, LLC 134
GW PHARMACEUTICALS PLC 135
HAMIDA PHARMA INC. 136
HANMI PHARMA CO. LTD. 136
HETEROGENEITY LLC 136
INDENA 137
INDUS BIOTECH 139
IZUN PHARMACEUTICALS CORP. 139
JOHNSON and JOHNSON 140
LANZHOU FOCI PHARMACEUTICALS CO. LTD. 141
LEO PHARMA 141
LUPIN LTD. 142
LUPIN PHARMACEUTICALS INC. 142
MEDIGENE 143
MEDIGENE INC. (U.S. DIVISION) 143
MERCK and CO. INC. 144
MERLION PHARMACEUTICALS 145
MICROBIO CO. LTD. 146
MYCOSYNTHETIX, INC. 147
NAPO PHARMACEUTICALS INC. 147
NOVARTIS INTERNATIONAL AG 148
PFIZER 149
THE PHARMACEUTICAL PLANT CO. 151
PHARMANUTRIENTS BOTANICAL CORP. 152
PHYNOVA 152
PHYTOCEUTICA INC. 153
PHYTOMYCO RESEARCH PVT. LTD. 154
PHYTOPHARMACON INC. 155
PIRAMAL PHYTOCARE LTD. 156
PRAIRIE PLANT SYSTEMS INC. 156
PUNISYN PHARMACEUTICALS LTD. (RIMONEST LTD.) 157
PURAPHARM INTERNATIONAL LTD. 157
PURGENESIS TECHNOLOGIES INC. 158
QUERCEGEN PHARMACEUTICALS LLC 158
ROTTAPHARM (MADAUS) 159
SANOFI 160
SCHWABE PHARMACEUTICALS 161
SE-CURE PHARMACEUTICALS LTD. 161
SEQUOIA SCIENCES INC. 162
SUN PHARMACEUTICAL INDUSTRIES LTD. 163
SUN TEN PHARMACEUTICAL CO. LTD. 164
TASLY PHARMACEUTICALS INC. 165
TCM BIOTECH INTERNATIONAL CORP. 166
TFS CORPORATION LTD. 167
VALEANT PHARMACEUTICALS INTERNATIONAL INC. 168
SALIX PHARMACEUTICALS INC. 168
VEDIC LIFESCIENCES PVT. LTD. 169
VIROXIS 170
XIANGXUE PHARMACEUTICALS, CO. LTD. 170
ZHEJIANG KANGLAITE GROUP 171
KANGLAITE USA 171
CHAPTER 7 APPENDIX 173
TABLE 24 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS 173
TABLE 25 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY 178

LIST OF TABLES

TABLE A FDA APPROVAL PROCESS FOR NEW DRUGS 5
SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS,
THROUGH 2020 ($ MILLIONS) 10
TABLE 1 KEY DATES IN BOTANICAL MEDICINE 18
TABLE 2 WELL KNOWN PLANT-DERIVED DRUGS 18
TABLE 3 SWOT ANALYSIS OF BOTANICAL DRUG DEVELOPMENT 32
TABLE 4 KEY INVESTMENTS IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 34
TABLE 5 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 43
TABLE 6 BOTANICAL COMPOSITION OF MENERBA (MF 101)* 56
TABLE 7 TOP PHARMA COMPANIES BY SALES, 2014 ($ BILLIONS) 61
TABLE 8 MAJOR UPCOMING U.S. PATENT EXPIRIES, 2014-2019 62
TABLE 9 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 77
TABLE 10 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES 79
TABLE 11 NUMBER OF FDA APPROVED BOTANICAL DRUGS, THROUGH 2020
(NUMBER) 82
TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY
THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS) 84
TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS IN LATE
STAGE DEVELOPMENT 88
TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE
DEVELOPMENT 89
TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE DRUGS 91
TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE DEVELOPMENT 92
TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE
STAGE DEVELOPMENT 94
TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION (BOTH NON-RELATED AND
RELATED TO ORTHOPEDIC) AND AUTOIMMUNE DRUGS IN LATE STAGE
DEVELOPMENT 95
TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE STAGE
DEVELOPMENT 97
TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE
DEVELOPMENT 98
TABLE 21 ESTIMATED U.S. CANCER CASES BY GENDER, 2015 99
TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE DEVELOPMENT 102
TABLE 23 BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT WITH POSSIBLE
FDA-APPROVED COMMERCIALIZATION, THROUGH 2020 109
TABLE 24 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS 173
TABLE 25 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY 178

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